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Treatment in the Rotterdam Early Arthritis CoHort
ISRCTN ISRCTN26791028
DOI 10.1186/ISRCTN26791028
ClinicalTrials.gov identifier
EudraCT number
Public title Treatment in the Rotterdam Early Arthritis CoHort
Scientific title Treatment in the Rotterdam Early Arthritis CoHort: a stratified, randomised clinical trial in patients with recent-onset arthritis
Acronym (T)REACH
Serial number at source NTR1019
Study hypothesis In each stratum of probability there is a clinically and statistically significant difference in the functional ability and disease activity score over time (area under the curve) and progression of radiological joint damage after one year of follow-up in recent-onset arthritic patients who were having induction treatment with divergent intensity.

On 23/04/2009 this record was updated; all amendments can be found under the relevant field. At this time, the anticipated end date of this record was updated - the initial anticipated end date at the time of registration was 15/11/2007.
Lay summary Not provided at time of registration
Ethics approval Medical Ethical Committee Erasmus University Rotterdam gave approval
Study design Multicentre randomised single-centre parallel-group trial
Countries of recruitment Netherlands
Disease/condition/study domain Recent onset arthritis, rheumatoid arthritis
Participants - inclusion criteria 1. Participant of the REACH cohort (patients with inflammatory joint complaints less then one year)
2. All patients must at least have one (out of 66) swollen joint

Added 23/04/2009:
3. Aged 18 years or older, either sex
Participants - exclusion criteria 1. Definite diagnosis of crystal arthropathy, (post) infective arthritis or autoimmune rheumatic disorder
2. Previous therapy with disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids
3. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
4. Concomitant treatment with an other experimental drug
5. History or presence of malignancy within the last five years
6. Elevated hepatic enzyme levels (aspartate aminotransferase [ASAT], alanine aminotransferase [ALAT] greater than two times normal value)
7. Thrombopoenia less than 150 x 10^9/l
8. Leucopoenia less than 3.0 x 10^9/l
9. Serum creatinine level greater than 150 umol/l
Anticipated start date 01/07/2007
Anticipated end date 01/07/2011
Status of trial Completed
Patient information material Can be found at: http://www.erasmusmc.nl/reumatologie/onderzoek/TREACH/
Target number of participants 810
Interventions Three monthly evaluations of disease activity score and safety. Medication adjustments by protocol, based on Disease Activity Score (DAS) calculations. If DAS is less than 2.4, medication will be switched to more intensive treatment including biologicals (initial biological will be etanersept). If DAS less than 1.6 is achieved for at least six months, patients will start to taper and finally stop all medication.

Induction therapy for the three strata will be:
1. High probability (HP)-group:
1.1. Methotrexate (MTX) + Sulfasalazine (SSZ) + Hydroxychloroquine (HCQ) + one single dose corticosteroid intramuscular
1.2. MTX + SSZ + HCQ + prednisone
1.3. MTX + prednisone
2. Intermediate Probability (IP)-group:
2.1. MTX
2.2. HCQ
2.3. Prednisone
3. Low Probability (LP)-group:
3.1. Naproxen
3.2. HCQ
3.3. One single dose corticosteroids intramuscular
Primary outcome measure(s) 1. Functional ability as measured by HAQ and DAS over time (area under the curve), assessed every 3 months
2. Progression of radiological joint damage as measured by Sharp/van der Heijde score, assessed every 6 months
Secondary outcome measure(s) 1. American College of Rheumatology (ACR) arthritis core-set, assessed every 3 months
2. Quality of Life, as measured with 36-item Short Form (SF-36), European Quality of Life scale (EuroQoL), assessed every 3 months
3. Costs
Sources of funding Wyeth Pharmaceutical B.V. (Netherlands)
Trial website
Publications 2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19538718
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22673898
2014 1-year results in: http://www.ncbi.nlm.nih.gov/pubmed/24788619
Contact name Prof  J.M.W.  Hazes
  Address Department of Rheumatology Ee965
  City/town Rotterdam
  Zip/Postcode 3000 WB
  Country Netherlands
  Tel +31 (0)10 703 4602
  Fax +31 (0)10 704 4593
  Email j.hazes@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address Department of Rheumatology
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Sponsor website: http://www.erasmusmc.nl/content/englishindex.htm
Date applied 23/08/2007
Last edited 21/08/2014
Date ISRCTN assigned 23/08/2007
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